Z-2946-2020Class II

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a...

Name: Z-2946-2020 Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a...
Creator: Smiths Medical ASD Inc.
Published: 2020-08-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-08-28 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may... on 2020-08-28. FDA classified it as Class II and gives the reason as "Label has the incorrect size for the tracheotomy tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2946-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-28
Posted: 2020-09-09
Terminated: 2021-05-13
Recalling firm: Abbott Medical
Product: Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Label has the incorrect size for the tracheotomy tube.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 08/28/20, the firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" to its consignees. The consignee was instructed to follow: INSTRUCTIONS TO CUSTOMERS: 1. Locate and quarantine the affected Bivona Mid-Range Aire-Cuf Tracheostomy Tubes in your possession by referring to the attached Urgent Medical Device Recall Response Form. This form identifies the one (1) specific lot number and quantity distributed to your facility. ONLY UNUSED PRODUCT SHOULD BE QUARANTINED FOR RETURN. 2. Complete the attached Urgent Medical Device Recall Form within 10 days of receipt and return it to [email protected]. The form must be returned even if you do not have any affected product in your possession. Product credit will be processed once the Urgent Medical Device Field Recall Response Form is received. 3. All affected product must be returned to Compliance at Smiths Medical for processing. Pre-paid shipping labels will be sent once you have returned the completed response form attached with this notice. Include a copy of your completed Response Form inside the package of returned product to facilitate processing. Make sure packages are sealed and labeled with your facility name prior to shipping to Smiths Medical. If you have any questions regarding this notification, please contact Smiths Medical via email at [email protected].
Quantity in commerce: 3 units
Distribution: US Distribution to state of: CT
Product codes and lots: Lot# 3952216

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2946-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2946-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-09

Product code JOH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)